Phase 4
Completed N=20
Effect of Samples on Acne Treatment With Epiduo® Gel
Source: ClinicalTrials.gov NCT01504204 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcomePrimary: Adherence to Study Medication — 86; 71 percentage of doses
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to compare adherence to treatment and efficacy with Epiduo® Gel in patients with mild to moderate acne who receive a medication sample and instructions on proper application with their stock size medication tube versus patients who receive only the stock size medication tube.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence to Study Medication |
86; 71 | — |
| SECONDARY Change in Acne Global Assessment |
5; 6; 4; 3; 0; 0 | — |
| SECONDARY Change in Acne Lesion Count |
3; 2; 33; 38; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subject with mild to moderate acne, aged 12 and older, who agrees to participate and provides written consent.
- Have an Acne Global Assessment (AGA) of mild to moderate acne (an AGA score of 2 or 3)
Exclusion Criteria
- Presence of a concurrent medical condition or skin condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.
- Subjects with known allergy or sensitivity to Epiduo® Gel (or Benzoyl Peroxide Gel) or components therein, including adapalene or benzoyl peroxide
- Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Reliable methods of birth control are: abstinence (not having sex), oral contraceptives, intrauterine device (IUD), Depo-Provera, tubal ligation, or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable, although less reliable, method involves the careful use of condoms and spermicidal foam or gel and/or a cervical cap or sponge. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
Data sourced from ClinicalTrials.gov (NCT01504204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.